Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-01 @ 11:09 PM
Study NCT ID:
NCT05034432
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2021-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIVATAL
Brief Summary:
To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery
Detailed Description:
This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA who will be randomized in a 1:1 ratio to intra-operative VTA ablation vs. conventional medical management. Comprehensive data on arrhythmia history, medication history will be collected in all randomized subjects. Antiarrhythmic medical therapy will be handled in a uniform pattern between the two arms. Randomized subjects will then be followed per routine schedules for post LVAD implant. Arrhythmia data, ICD therapy, additional procedures including repeat surgery, ramp echocardiographic tests, right heart catheterization and catheter-based VTA ablation will be collected. In addition, adverse events such as unplanned hospitalizations, emergency department visits, clinic visits, and all other aspects of health care utilization will be gathered. The planned average follow-up period will be 18 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL159401 | NIH | None | https://reporter.nih.gov/quic… | View |